U.S. patent application number 14/610968 was filed with the patent office on 2015-05-28 for systems, apparatus, methods, and procedures for the non-invasive treatment of tissue using microwave energy.
The applicant listed for this patent is Yoav BEN-HAIM, Sunmi CHEW, Dong Hoon CHUN, Daniel FRANCIS, Jessi E. JOHNSON, Steven KIM, Leo KOPELOW, Christopher LOEW, Alexey SALAMINI, Ted SU. Invention is credited to Yoav BEN-HAIM, Sunmi CHEW, Dong Hoon CHUN, Daniel FRANCIS, Jessi E. JOHNSON, Steven KIM, Leo KOPELOW, Christopher LOEW, Alexey SALAMINI, Ted SU.
Application Number | 20150148792 14/610968 |
Document ID | / |
Family ID | 44122779 |
Filed Date | 2015-05-28 |
United States Patent
Application |
20150148792 |
Kind Code |
A1 |
KIM; Steven ; et
al. |
May 28, 2015 |
SYSTEMS, APPARATUS, METHODS, AND PROCEDURES FOR THE NON-INVASIVE
TREATMENT OF TISSUE USING MICROWAVE ENERGY
Abstract
A system applies, in a non-invasive manner, energy to a targeted
tissue region employing a controlled source of energy, a multiple
use applicator, and a single use, applicator-tissue interface
carried by the applicator. The system can generate and apply energy
in a controlled fashion to form a predefined pattern of lesions
that provide therapeutic benefit, e.g., to moderate or interrupt
function of the sweat glands in the underarm (axilla).
Inventors: |
KIM; Steven; (Los Altos,
CA) ; FRANCIS; Daniel; (Mountain View, CA) ;
JOHNSON; Jessi E.; (Sunnyvale, CA) ; SALAMINI;
Alexey; (San Francisco, CA) ; SU; Ted;
(Sunnyvale, CA) ; CHUN; Dong Hoon; (Sunnyvale,
CA) ; BEN-HAIM; Yoav; (San Francisco, CA) ;
LOEW; Christopher; (Palo Alto, CA) ; KOPELOW;
Leo; (San Francisco, CA) ; CHEW; Sunmi; (San
Jose, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
KIM; Steven
FRANCIS; Daniel
JOHNSON; Jessi E.
SALAMINI; Alexey
SU; Ted
CHUN; Dong Hoon
BEN-HAIM; Yoav
LOEW; Christopher
KOPELOW; Leo
CHEW; Sunmi |
Los Altos
Mountain View
Sunnyvale
San Francisco
Sunnyvale
Sunnyvale
San Francisco
Palo Alto
San Francisco
San Jose |
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA |
US
US
US
US
US
US
US
US
US
US |
|
|
Family ID: |
44122779 |
Appl. No.: |
14/610968 |
Filed: |
January 30, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13123756 |
Apr 12, 2011 |
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PCT/US2009/005772 |
Oct 22, 2009 |
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14610968 |
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PCT/US08/13650 |
Dec 12, 2008 |
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13123756 |
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PCT/US09/02403 |
Apr 17, 2009 |
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PCT/US08/13650 |
|
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61279153 |
Oct 16, 2009 |
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61208315 |
Feb 23, 2009 |
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61196948 |
Oct 22, 2008 |
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Current U.S.
Class: |
606/33 |
Current CPC
Class: |
A61B 2017/306 20130101;
A61B 2090/372 20160201; A61B 2034/252 20160201; A61B 2034/254
20160201; A61H 9/0057 20130101; A61N 5/02 20130101; A61B 2017/00477
20130101; A61B 2018/183 20130101; A61B 18/1815 20130101; A61B
2018/00023 20130101; A61B 2017/00115 20130101; A61B 2017/00199
20130101; A61B 2018/00702 20130101; A61B 18/18 20130101 |
Class at
Publication: |
606/33 |
International
Class: |
A61B 18/18 20060101
A61B018/18 |
Claims
1. A method of driving the antennas in an array of microwave
antennas, the method comprising the steps of: positioning an
apparatus including a plurality of waveguide antennas; inputting
control information into a Graphical User Interface, wherein a
master controller responds to outputs from the Graphical User
Interface by: applying microwave energy by a first waveguide
antenna; applying microwave energy concurrently by the first
waveguide antenna and a second waveguide antenna wherein the second
waveguide antenna is a next adjacent antenna to the first waveguide
antenna and wherein the microwave energy supplied to adjacent
antennas is in-phase; and applying microwave energy by the second
antenna alone.
2. The method of claim 1 further comprising the additional steps
of: applying microwave energy concurrently by the second waveguide
antenna and a third waveguide antenna wherein the third waveguide
antenna is the next adjacent antenna to the second waveguide
antenna; and applying microwave energy by the third antenna
alone.
3. The method of claim 2 further comprising the additional steps
of: applying microwave energy concurrently by the third waveguide
antenna and a fourth waveguide antenna wherein the fourth waveguide
antenna is the next adjacent antenna to the third waveguide antenna
and wherein the microwave power supplied to adjacent antennas is
in-phase; and applying microwave energy by the fourth antenna
alone.
4. The method of claim 1 wherein there is a phase difference of
zero degrees between radiated signals from adjacent waveguide
antennas.
5. The method of claim 1 wherein, when the first and second
waveguide antennas are driven concurrently, each radiates one-half
of the supplied power.
6. The method of claim 5 wherein the supplied microwave energy is
divided in half and fed into each waveguide antenna.
7. The method of claim 1 wherein microwave energy is applied to
each antenna or each pair of antennas for an equal time
increment.
8. The method of claim 1 wherein the microwave energy is radiated
at a frequency of 5.8 GHz.
9. An apparatus including an array of microwave antennas, the
apparatus comprising: a Graphical User Interface and a master
controller, wherein the master controller responds to outputs from
the Graphical User Interface to control: a first waveguide antenna
adapted to radiate microwave energy; means for applying microwave
energy concurrently by the first waveguide antenna and a second
waveguide antenna wherein the second waveguide antenna is a next
adjacent antenna to the first waveguide antenna and wherein the
microwave energy supplied to adjacent antennas is in-phase; and
means for applying microwave energy by the second antenna
alone.
10. The apparatus of claim 9, further comprising: means for
applying microwave energy concurrently by the second waveguide
antenna and a third waveguide antenna wherein the third waveguide
antenna is a next adjacent antenna to the second waveguide antenna;
and means for applying microwave energy by the third antenna
alone.
11. The apparatus of claim 9 further comprising: means for applying
microwave energy concurrently by the third waveguide antenna and a
fourth waveguide antenna wherein the fourth waveguide antenna is a
next adjacent antenna to the third waveguide antenna and wherein
the microwave energy supplied to adjacent antennas is in-phase; and
means for applying microwave energy by the fourth antenna
alone.
12. The apparatus of claim 9 wherein there is a phase difference of
zero degrees between radiated signals from adjacent waveguide
antennas.
13. The apparatus of claim 9 wherein, when two antennas are driven
concurrently, each radiates one-half of the supplied power.
14. The apparatus of claim 13 wherein the microwave energy is
divided in half and fed into each antenna.
15. The apparatus of claim 9 wherein microwave energy is applied to
each antenna or each pair of antennas for an equal time
increment.
16. The apparatus of claim 9 wherein the microwave energy is
radiated at a frequency of 5.8 GHz.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 13/123,756, filed Apr. 12, 2011, which is the national phase of
International Application No. PCT/US2009/005772, filed Oct. 22,
2009, incorporated herein by reference.
[0002] This application claims the benefit of U.S. Provisional
Patent Application Ser. No. 61/208,315, filed Feb. 23, 2009, and
entitled "Systems, Apparatus, Methods And Procedures For The
Noninvasive Treatment Of Tissue Using Microwave Energy," which is
expressly incorporated herein by reference in its entirety.
[0003] This application also claims the benefit of PCT Application
Serial No. PCT/US2008/013650, filed Dec. 12, 2008, and entitled
"Systems, Apparatus, Methods And Procedures For The Noninvasive
Treatment Of Tissue Using Microwave Energy," which is expressly
incorporated herein by reference in its entirety.
[0004] This application also claims the benefit of U.S. Provisional
Patent Application Ser. No. 61/196,948, filed Oct. 22, 2008, and
entitled "Systems And Methods For Creating An Effect Using
Microwave Energy To Specified Tissue, Such As Sweat Glands," which
is expressly incorporated herein by reference in its entirety.
[0005] This application also claims the benefit of PCT Application
Serial No. PCT/US2009/002403 filed 17 Apr. 2009 and entitled
"Systems, Apparatus, Methods and Procedures for the Noninvasive
Treatment of Tissue Using Microwave Energy".
[0006] This application also claims the benefit of co-pending
provisional U.S. patent application Ser. No. ______ filed 16 Oct.
2009, and entitled "Systems, Apparatus, Methods, and Procedures for
the Non-Invasive Treatment of Tissue Using Microwave Energy".
[0007] This application is also a continuation-in-part of
co-pending U.S. patent application Ser. No. 12/107,025, filed Apr.
21, 2008, and entitled "Systems And Methods For Creating An Effect
Using Microwave Energy To Specified Tissue," which claims the
benefit of each of U.S. Provisional Patent Application Ser. No.
60/912,899, filed Apr. 19, 2007, and entitled "Methods And
Apparatus For Reducing Sweat Production;" and U.S. Provisional
Patent Application Ser. No. 61/013,274, filed Dec. 12, 2007, and
entitled "Methods, Devices And Systems For Non-Invasive Delivery Of
Microwave Therapy;" and U.S. Provisional Patent Application Ser.
No. 61/045,937, filed Apr. 17, 2008, and entitled "Systems And
Methods For Creating An Effect Using Microwave Energy In Specified
Tissue." All of the above priority applications are expressly
incorporated by reference in their entirety.
[0008] Co-pending U.S. patent application Ser. No. 12/107,025 also
claims priority to each of PCT Application Serial. No.
PCT/US08/60935, filed Apr. 18, 2008, and entitled "Methods And
Apparatus For Sweat Production"; and PCT Application Serial No.
PCT/US08/60929, filed Apr. 18, 2008, and entitled "Methods,
Devices, And Systems For Non-Invasive Delivery Of Microwave
Therapy"; and PCT Application Serial No. PCT/US08/60940, filed Apr.
18, 2008, and entitled "Systems And Methods For Creating An Effect
Using Microwave Energy To Specified Tissue"; and PCT Application
Serial No. PCT/US08/60922, filed Apr. 18, 2008, and entitled
"Systems And Methods For Creating An Effect Using Microwave Energy
To Specified Tissue."
[0009] All of the above priority applications are expressly
incorporated by reference in their entirety.
FIELD OF THE INVENTION
[0010] The present application relates to methods, apparatuses, and
systems for the non-invasive delivery of energy, including
microwave energy. In particular, the present application relates to
methods, apparatuses, and systems for non-invasively delivering
energy, such as, e.g., microwave energy, to epidermal, dermal, and
sub-dermal tissue of an individual to achieve various therapeutic
and/or aesthetic results.
BACKGROUND OF THE INVENTION
[0011] It is known that energy-based therapies can be applied to
tissue throughout the body to achieve numerous therapeutic and/or
aesthetic results. There remains a continual need to improve on the
effectiveness of these energy-based therapies and provide enhanced
therapeutic results with minimal adverse side effects or
discomfort.
SUMMARY OF THE INVENTION
[0012] Systems and methods apply, in a non-invasive manner, energy
to a targeted tissue region employing a controlled source of
energy, an applicator, and an applicator-tissue interface carried
by the applicator. The systems and methods can generate and apply
energy in a controlled fashion to form a predefined pattern of
lesions that provide therapeutic benefit, e.g., to moderate or
interrupt function of the sweat glands in the underarm
(axilla).
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a perspective view of a system for applying, in a
non-invasive manner, forms of energy to body tissue to achieve
desired therapeutic and/or aesthetic results comprising a console,
an applicator, and an applicator-tissue interface.
[0014] FIGS. 2 to 4 are side and rear perspective views of the
console shown in FIG. 1.
[0015] FIGS. 5 and 6 are perspective views of the applicator and
applicator-tissue interface shown in FIG. 1, with FIG. 5 showing
the applicator-tissue interface joined to the applicator for use
and FIG. 6 showing the applicator-tissue interface detached from
the applicator prior to or after use.
[0016] FIG. 7 is an exploded perspective view of the applicator
shown in FIGS. 5 and 6.
[0017] FIG. 8 is an assembled interior view of the applicator shown
in FIG. 7.
[0018] FIG. 9 is an exploded perspective view of the waveguide
antenna array, waveguide cradle, and cooling plate carried on-board
the applicator shown in FIG. 7.
[0019] FIG. 10 is an assembled perspective view of the waveguide
antenna array, waveguide cradle, and cooling plate shown in FIG.
9.
[0020] FIG. 11 is a bottom view, partially broken away, of the
waveguide antenna array, waveguide cradle, and cooling plate shown
in FIG. 10.
[0021] FIG. 12A is an exploded perspective view of the
applicator-tissue interface shown in FIG. 6.
[0022] FIG. 12B is an assembled side section perspective view of
the applicator-tissue interface shown in FIG. 12A.
[0023] FIG. 13 is an assembled, bottom perspective view of the
applicator-tissue interface attached to the waveguide antenna
array, waveguide cradle, and cooling plate of the applicator for
use.
[0024] FIGS. 14A and 14B are top and bottom plane views of a
applicator-tissue interface with interior patterns along its
interior that may impress a "hickey pattern" on the skin drawn into
the chamber.
[0025] FIG. 15 is a schematic view of the system shown in FIG.
1.
[0026] FIGS. 16A and 16B are views of the custom designed
multi-function plug at one end of the special purpose cable
assembly that couples the applicator to the console, as shown in
FIG. 1.
[0027] FIGS. 16C and 16D are views of the vacuum trap that couples
the applicator-tissue interface to the console, as shown in FIG.
1.
[0028] FIGS. 17 and 18 are schematic views of the circuitry of the
forward and reverse power detectors that may be carried on-board
the applicator shown in FIG. 1.
[0029] FIG. 19A is a perspective view of the LED Indicator Board
carried on-board the applicator and its functionality.
[0030] FIGS. 19B, C, D, and E are illustrative views of LED
displays that the LED Indicator Board shown in FIG. 19A can present
to the caregiver holding the applicator.
[0031] FIG. 20 is a simplified anatomic side section view of human
skin.
[0032] FIG. 21A is a partially schematic side section view of the
applicator and applicator-tissue interface placed into contact with
human skin prior to application of vacuum to the tissue acquisition
chamber.
[0033] FIG. 21B is a partially schematic side section view of the
applicator and applicator-tissue interface placed into contact with
human skin after application of vacuum to the tissue acquisition
chamber to draw skin into the chamber for treatment.
[0034] FIG. 22A is a partially schematic side section view of the
applicator and applicator-tissue interface placed into contact with
human skin after application of vacuum to the tissue acquisition
chamber to draw skin into the chamber for treatment, and after the
application of energy through a single waveguide antenna.
[0035] FIG. 22B is a schematic view of a lesion formed after the
application of energy through a single waveguide antenna as shown
in FIG. 22A.
[0036] FIG. 23A is a partially schematic side section view of the
applicator and applicator-tissue interface placed into contact with
human skin after application of vacuum to the tissue acquisition
chamber to draw skin into the chamber for treatment, and after the
application of energy through adjacent waveguide antennas in a
phase drive mode.
[0037] FIG. 23B is a schematic view of a lesion pattern formed
after the successive application of energy through single and
adjacent waveguide antennas as shown in FIGS. 22A and 23A.
[0038] FIGS. 24A and 24B are views of representative treatment
templates for use in methods and procedures according to the
present invention.
[0039] FIG. 25 are perspective views of packaging for the
applicator and applicator-tissue interface shown in FIG. 1 in kits
together with instructions for use.
[0040] FIG. 26 is a perspective view of the display screen shown in
FIG. 1, showing a screen of a representative graphical user
interface.
[0041] FIGS. 27 to 31 are schematic views of the logic and control
components of a representative graphical user interface, which
includes step-by-step instructions for using the components of the
system, with cross reference to representative graphical screen
shots.
[0042] FIGS. 32 to 59 are screen shots of a representative
graphical user interface executed according to the logic shown in
FIGS. 27 to 31.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0043] This Specification discloses various systems and methods for
applying, in a non-invasive manner, forms of energy to body tissue
to achieve desired therapeutic and/or aesthetic results. As
described, the systems and methods are particularly well suited for
treating the epidermal, dermal, and sub-dermal tissue of an
individual to treat, e.g., skin conditions, aesthetic conditions,
glandular structures, vascular structures, or hair follicles. For
this reason, the systems and methods will be described in this
context, and, in particular, in the context of the application of
electromagnetic microwave energy to sweat glands to treat
hyperhidrosis, or excessive seating.
[0044] Still, it should be appreciated that the disclosed systems
and methods are applicable for use in applying, in a non-invasive
manner, microwave or other forms of energy to treat other
conditions elsewhere in the body. Further, although the disclosure
contained in this Specification is detailed and exact to enable
those skilled in the art to practice the invention, the physical
embodiments disclosed are intended to exemplify representative
embodiments that highlight the technical features of the invention.
The technical features of the invention may be embodied in other
specific structures. While the preferred embodiments have been
described, the details may be changed without departing from the
technical features of the invention as defined in the claims.
I. System Overview
[0045] FIG. 1 shows a system 10 for applying, in a non-invasive
manner, energy to a targeted tissue region that embodies the
features of the invention. As shown in FIG. 1, the system 10
includes three main components. These are a system console 12; a
system applicator 14; and an applicator-tissue interface 16 carried
by the system applicator 14.
[0046] In the illustrative embodiment shown in FIG. 1, and as will
be described in further detail later, the system 10 is particularly
sized and configured to generate and apply energy to the underarm
(axilla) of an individual to form a predefined pattern of lesions
(see, e.g., FIG. 23B). The pattern of lesions serves, e.g., to
moderate or interrupt function of the sweat glands in the underarm.
In this illustrative arrangement, the system 10 and its method of
use can serve to treat, e.g., axillary hyperhidrosis or underarm
sweating/odor.
[0047] A. The System Console
[0048] In the illustrative embodiment, the system console 12 may be
a durable item capable of repeated re-use. As FIGS. 1 to 4 show,
the system console 12 comprises a cabinet or housing that is
compact and capable of being wheeled for transport and positioning
alongside an individual to be treated. Components housed within the
console support specified treatment functions. An AC power cable 18
couples components within the system console 12 to a standard AC
power outlet (see FIG. 4). A power supply within the system console
12 (see FIG. 15) converts the power to 12V DC power for
distribution to the components housed within the system console
12.
[0049] In the illustrated embodiment, the specified system
functions include an energy generation function; a tissue
acquisition function; a lesion creation function; and a lesion
control function.
[0050] B. The System Applicator
[0051] The system applicator 14 also may be a durable item capable
of repeated re-use. The system applicator 14 may be sized and
configured to be, during use, conveniently handled and manipulated
in a hand of a caregiver (see FIG. 1). As FIGS. 2 and 3 show, the
system applicator 14 may be conveniently rested in a holster 20 on
the system console 12.
[0052] As shown in FIGS. 1 and 5 to 8, the system applicator 14
comprises a pistol-grip housing made, e.g., of molded plastic
material. Carried within the housing is a waveguide antenna array
22 (see FIGS. 7 to 11). In the illustrated embodiment, the
waveguide antenna array 22 comprises four waveguide antennas 24. It
should be appreciated that the number of antennas 24 can vary
according to the treatment objectives.
[0053] In use, the waveguide antenna array 22 radiates energy
provided by the energy generation function.
[0054] Components in the applicator 14 also act in concert with
components housed within the system console 12 to carry out the
lesion generation and lesion control functions. More particularly,
and will be described in greater detail later, the lesion
generation function controlled within the console 12 operates a
microwave switch 26 in the applicator 14 (see FIG. 7) to
synchronize the radiation of energy by the antennas 24 in the
applicator 14 to form desired patterns of lesions in the targeted
tissue region (as FIG. 23B shows). Further, and as will also be
described in more detail later, the lesion control function
controlled within the console 12 provides a coolant that is
circulated to a cooling plate 28 in the applicator 14 (see FIG. 7)
that is in thermal conductive contact with the targeted tissue
region. The temperature conditions of the cooling plate 28 control
expansion of the lesion in the targeted tissue region.
[0055] A "trigger" switch 30 on the system applicator 14 (see FIG.
7), which may, for example, be thumb actuated, gives the caregiver
direct control over initiation and termination of treatment,
subject to the overrides and global control of the master
controller of the system console 12. Alternatively, or in
combination, a foot pedal control switch 32 can be provided for the
same purpose (see FIG. 1). A special purpose cable assembly 34 (see
FIGS. 1 and 16A/B) couples the components housed in the system
applicator 14 to the components housed within the system console
12. The special purpose cable assembly 34 includes a custom
designed multi-function plug 36 that couples to a dedicated
connection 38 site on the system console 12.
[0056] C. The Applicator-Tissue Interface
[0057] The applicator-tissue interface 16 may be a single use,
disposable item. More particularly, as shown in FIGS. 6; 12A/B; and
13, the interface 16 may be sized and configured to be temporarily
coupled to the system applicator 14 during use (e.g., by a latching
mechanism 40), and then detached after use for disposal, as shown
in FIG. 6. In this arrangement, the applicator-tissue interface 16
can, after an incidence of use, be detached from the system
applicator 14, discarded, and replaced by another unused
applicator-tissue interface 16 prior to a next incidence of
use.
[0058] In use (e.g., see FIGS. 21A and 21B), the applicator-tissue
interface 16 contacts the targeted tissue region and passes the
energy radiated by the waveguide antenna array 22 to tissue.
Components in the applicator-tissue interface 16 also act in
concert with components housed within the system console 12 to
carry out the tissue acquisition function. For this purpose, the
applicator-tissue interface 16 includes a tissue acquisition
chamber 42, into which tissue is drawn to elevate the dermis and
hypodermis and localize and stabilize the targeted tissue region in
thermal conductive contact with the cooling plate 28 as energy is
applied from the waveguide antenna array 22. In the illustrated
embodiment, the tissue acquisition function includes the
application of a vacuum to the tissue acquisition chamber 42. For
this purpose, a vacuum supply conduit 44 couples the components
housed in the applicator-tissue interface 16 to components housed
within the system console 12. The vacuum supply conduit 44 plugs
into a dedicated connection site 48 on the system console 12.
[0059] The application of the vacuum by the applicator-tissue
interface 16, as controlled by the tissue acquisition function,
provides uniformity and consistency in acquiring tissue for
treatment. It reduces variability of treatment that may arise,
e.g., due to differences in manipulation of the applicator by a
given caregiver and/or difference among tissue topologies to be
treated.
[0060] The applicator-tissue interface 16 also includes a
multi-functional bio-barrier 50 (see FIG. 12A). As will be
described in greater detail later, the multi-functional bio-barrier
50 isolates the operational components in the applicator 14 and the
console 12 from contact with and contamination by physiologic
liquids (e.g., blood and sweat) that may be present in the targeted
tissue region. The multi-functional bio-barrier 50 substantially
isolates the durable electrical and mechanical components of the
system 10 (e.g., the applicator 14 and console 12), from the
physiologic conditions of the tissue regions being treated, and
vice versa.
II. The Functions of the System
[0061] As will be described, a master controller 58 housed on-board
the system console 12 (see FIG. 15) monitors, controls, and
coordinates the overall execution of the specified energy
generation function, the tissue acquisition function, the lesion
creation function, and the lesion control function by the system
10. The on-board master controller 58 serves to globally set and
control output power, as well as the sequence of the application of
the waveform to the system applicator and waveguide antennas 24
within the applicator 14. The on-board master controller 58 also
monitors operational conditions and initiates alarms when
predetermined error or out of bound conditions occur.
[0062] An applicator control board 60 housed within the applicator
14 (see, e.g., FIGS. 7 and 15) communicates with the master
controller 58 and is controlled by the master controller 58 to
support the energy generation function, the lesion creation
function, and the lesion control function conducted by the
applicator 14.
[0063] The master controller 58 may also implement a graphical user
interface 62 (see, e.g., FIG. 26). The graphical user interface 62
may be generated on a display screen 64 that articulates on the
system console 12, as FIGS. 1 and 3 show). The graphical user
interface 62 conveys status and operational information to the
caregiver and allows the caregiver to provide control inputs. The
graphical user interface 62 on the display screen 64 communicates
the control and alarm conditions to the caregiver and allows for
touch-screen interaction and input from the caregiver. Further
details of a representative graphical user interface 62 will be
described later (and, in particular, are shown in FIGS. 27 to
59).
[0064] The energy generation function; the tissue acquisition
function; the lesion creation function; and the lesion control
function, as well as the principal cooperating components on the
console 12, applicator 14, and applicator-tissue interface 16 that
execute these functions will now be individually discussed in
greater detail.
[0065] A. The Energy Generation Function
[0066] Components carried on-board the system console 12 (see FIG.
15) generate an energy waveform selected to achieve the desired
therapeutic objective in the targeted tissue region. These
components include a microwave generator 66 (Broadband Wireless,
Model Number BW-5800-125-HS). The master controller 58 on-board the
system console 12 includes preprogrammed rules or logic that set
and/or vary the output power of the microwave generator 66
according to the therapeutic objectives of a given system.
[0067] Given the therapeutic objectives of treating hyperhidrosis,
the microwave generator 66, under the control of the master
controller 58, may generate at the time of treatment a microwave
signal that lays in the ISM band of 5.775 to 5.825 GHz, with a
frequency centered at approximately 5.8 GHz. Of course, other
waveforms or variations in this waveform can be selected for
generation by the waveform generation function. A microwave cable
68 in the special purpose cable assembly 34 couples the microwave
signal to the system applicator 14.
[0068] The master controller 58 may set the power output for the
microwave signal at between approximately 40 Watts and
approximately 100 Watts, where the power output is measured into a
50 ohm load. As another example, the master controller 58 may set a
power output at approximately 55 Watts measured into a 50 ohm load.
The power output may be matched to the impedance of the system
applicator 14, the special purpose cable assembly 34, and the
applicator-tissue interface 16 to provide appropriate power out of
the system applicator 14 at the frequency of interest.
[0069] The system applicator 14 carries the waveguide antenna array
22 (see FIGS. 9 and 10). The applicator also carries a microwave
switch 26 (see FIGS. 7 and 8) coupled to the microwave cable 68 of
the special purpose cable assembly 34. Feed connectors 70 from the
switch 26 couple to the four waveguide antennas 24 of the waveguide
antenna array 22 (see FIG. 8).
[0070] The master controller 58 on-board the system console 12
includes preprogrammed rules or logic to distribute the microwave
signal in a predetermined pattern to the waveguide antennas 24.
Preprogrammed rules or logic on the applicator main board 60
convert the control signal pattern to switching signals, which are
communicated to the microwave switch 26 in the applicator 14. In
response, the antennas 24 radiate the microwave signal through the
applicator-tissue interface 16 in a predetermined pattern
(controlled by the lesion generation function) to form prescribed
lesion patterns in the targeted tissue region (as shown, e.g., in
FIG. 23B).
[0071] The assembly of the waveguide antenna array 22 can vary. In
the representative illustrated embodiment (see, in particular,
FIGS. 9 and 10), the array of waveguide antennas 24 is supported
within the system applicator 14 by an antenna cradle 72 and
waveguide assembly 74. A cooling plate 28 supported on the antenna
cradle 72 faces the applicator-tissue interface 16. As will be
described in greater detail later, the cooling plate 28 is one
component of a cooling system controlled by the master controller
58 that may serve to control lesion formation, by, for example,
preventing lesions from expanding toward the surface of the skin as
they are formed by the applied microwave energy.
[0072] In the illustrated embodiment (see FIG. 9), the waveguide
assembly includes spacers 76 (which may be, for example, a metal
material such as copper or aluminum shims) positioned between
waveguide antennas 24. The thickness of the spacers 76 is selected
to manipulate the shape of the power distribution pattern applied
when, for example, adjacent waveguide antennas 24 are commanded to
radiate power (which is called a phase drive mode, as will be
described in greater detail later). As shown in FIG. 9, the heights
of waveguide antennas 24 in the waveguide antenna array 22 are
staggered to facilitate access to the feed connectors 70. Each
waveguide antenna 24 may be manufactured by coating a dielectric
center region with a metal material, e.g., copper or nickel. The
thickness of the metal material may, at a minimum, correspond to
the skin depth of the applied microwave energy at the frequency of
interest, e.g., 5.8 GHz. Typically, the thickness is significantly
greater, e.g., 0.00025 inches or more.
[0073] In the illustrated embodiment (see FIG. 9), each waveguide
antenna 24 may include at least one scattering element 78, which
projects from its lower, tissue facing surface, which can also be
called the antenna aperture. The scattering elements 78 are sized
and configured to optimize the size and shape the lesions. In the
illustrated embodiment, each scattering element 78 projects toward
tissue generally from the center of the respective waveguide
antenna aperture. Still, in an alternative embodiment, the
scattering element 78 need not be centered on the waveguide antenna
aperture. The scattering element 78 may project about 1 mm from the
aperture.
[0074] In the illustrated embodiment (see FIG. 9), intermediate
scattering elements 80 may be positioned between the waveguide
antennas 24. The intermediate scattering elements 80 may be sized
and configured to optimize the size and shape of lesions developed
in the skin between waveguide antennas 24, for example, by
improving the Specific Absorption Rate (SAR) pattern in tissue. By
altering the material, size, and configuration of the intermediate
scattering elements 80, lesions created in tissue by the waveguide
antennas 24 can be made larger and more spread out, or (conversely)
narrower, depending upon the therapeutic objectives. For example,
increasing the dielectric constant of an intermediate scattering
element 80 may reduce the size of a lesion created in skin between
waveguide antennas 24, and vice versa.
[0075] The intermediate scattering elements 80 may be manufactured
from, for example, alumina or from a material that is approximately
96% alumina. Alternatively, the intermediate scattering elements 80
may be manufactured from, for example, silicone or injected molded
silicone. The intermediate scattering elements 80 may be
manufactured from a material having approximately the same
dielectric constant as the scattering elements 78, e.g., a
dielectric constant of approximately 10, and more preferred, a
dielectric constant of approximately 3.
[0076] The intermediate scattering elements 80 may be sized such
that they have a width which is not more than slightly wider than
the separation distance between apertures of the waveguide antennas
24, so that they do not substantially interfere with the radiated
energy. The intermediate scattering elements 80 may be sized and
configured to modify and/or spread out the radiated microwave
field.
[0077] In a representative embodiment, the intermediate scattering
elements 80 may have an optimal length which is shorter than the
length of scattering elements 78, e.g., approximately 7 mm in
length, or more preferred 6.3 mm in length.
[0078] 1. The Tissue Acquisition Function
[0079] Components carried on-board the system console 12 (see FIG.
15) generate negative pressure that is communicated to the
applicator-tissue interface 16 by the vacuum supply conduit 44. As
will be described in greater detail later (and as generally
illustrated in FIG. 12B), the applicator-tissue interface 16
includes a formed tissue acquisition chamber 42 with ports 82
through which negative pressure is directed by the vacuum supply
conduit 44 to draw tissue into the acquisition chamber 42, as FIG.
21B shows). The negative pressure applied to tissue in the
acquisition chamber 42 localizes and stabilizes the tissue while
microwave energy is applied.
[0080] The tissue acquisition function can be accomplished in
concert with the tissue acquisition chamber 42 in various ways. In
the illustrated embodiment (see FIG. 15), the tissue acquisition
function includes a motor-driven vacuum pump 84 coupled via a
one-way check valve 86 and accumulator (reservoir) 88 to a solenoid
vacuum valve 90. The check valve 86 between the vacuum pump 84 and
the accumulator 88 allows the vacuum pump 84 to be shut off when no
additional vacuum is required. The accumulator (reservoir) 88 may
accommodate, e.g., at least 30 cubic inches in volume to provide a
large capacity of vacuum.
[0081] The vacuum pump 84 may comprise, e.g., a scroll vacuum pump
with a brushless DC motor (Air Squared Model No. V11H12N2.5). The
solenoid vacuum valve 90 may comprise. e.g., a solenoid valve,
three way, normally closed, exhaust to atmosphere (Model
LW53KK8DGBG12/DC, Peter Paul Electronics, Co.). The vacuum pump 84
maintains, e.g., a vacuum level of between minus 20 inches to minus
22 inches of Hg for proper tissue acquisition.
[0082] As FIG. 15 shows, the motor-driven vacuum pump 84 may
receive power through the power supply and power printed circuit
board (PCB) within the system console 12. The solenoid vacuum valve
90 may also be coupled to and controlled by the master controller
58 on-board the system console 12, so that its operation can be
coordinated by the master controller 58 with the generation and
application of microwave energy, as well as other functions of the
system 10.
[0083] The motor-driven vacuum pump 84 creates negative pressure.
The solenoid vacuum valve 90 communicates with the vacuum supply
conduit 44. When opened by the master controller 58, the solenoid
vacuum valve 90 conveys negative pressure generated by the vacuum
pump 84 to the tissue acquisition chamber 42 of the
applicator-tissue interface 16. Closing the solenoid vacuum valve
90 interrupts the supply of negative pressure to the
applicator-tissue interface 16.
[0084] Referring now to FIGS. 12A and 12B, the applicator-tissue
interface 16 may comprise a body 92 formed from a medical grade
rigid or semi-rigid plastic material, e.g., polycarbonate. The body
92 may be formed, e.g., by molding, into a bowl shape. Latching
assembly 40 can be integrally formed on the body 92 to couple to a
mating attachment member 94 on the system applicator 14 (see, e.g.,
FIG. 5), to fasten the applicator-tissue interface 16 to the system
applicator 14 at time of use and disconnect the interface from the
system applicator 14 after use (as FIGS. 5 and 6 illustrate).
[0085] Within the bowl shaped body 92 (as best shown in FIG. 12B),
a waveguide holder gasket 96 is seated on peripheral flange 98
formed in the bowl. The waveguide holder gasket 96 is sized and
configured, when the interface body 92 is fastened to the system
applicator 14 (see FIG. 13), to form a fluid-tight, pressure-tight
seal against the periphery of the cooling plate 28 on the
undersurface of the waveguide assembly.
[0086] Within the bowl shape body 92 (see FIGS. 12A and 12B),
spaced below and inward of the waveguide holder gasket 96, is a
tissue interface surface 100. In the illustrated embodiment (as
best shown in FIG. 12A), the tissue interface surface 100 comprises
a frame 102 with upper and lower overlying adhesive panels 104. A
first bio-barrier component 52 is mounted on the upper adhesive
panel, and the lower adhesive panel adheres to an interface surface
support in the bowl, which the waveguide holder gasket 96
peripherally surrounds.
[0087] In use, tissue being treated contacts the first bio-barrier
component 52 in thermal contact with at least a portion of the
cooling plate 28. The first bio-barrier component 52 forms a part
of the multi-functional bio-barrier 50 of the applicator-tissue
interface 16. The first bio-barrier component 52 forms comprises
the actual tissue surface interface, which tissue acquired within
the tissue acquisition chamber 42 contacts as energy is applied
from the waveguide antenna array 22. The first bio-barrier
comprises 52 a material that is selected on the basis of different,
but overlapping physical criteria.
[0088] One selection criteria for the first bio-barrier component
52 is that the material is substantially impermeable to both air
and liquids, such as blood and/or sweat, which may be present in
the tissue acquisition chamber 42. As the tissue acquisition
function applies vacuum to draw tissue within the tissue
acquisition chamber 42 into contact with the first bio-barrier
component 52, the first bio-barrier component 52 isolates the
components in the applicator 14 from contact with and contamination
by physiologic liquid in the targeted tissue region.
[0089] An overlapping selection criteria for the first bio-barrier
component 52 is that the material, taking into account its
thickness, possesses requisite low microwave conductivity, so that
it efficiently passes the microwave energy radiated by the
waveguide antenna array 22 to the targeted tissue region acquired
within the tissue acquisition chamber 42, with minimal energy
absorption. This characteristic can be expressed as a loss tangent
tan .delta. of 0.1 or less, and more desirably approximately
0.0004.
[0090] The loss tangent tan .delta. is similar to conductivity
.sigma., but also takes into account the dielectric constant of the
material, as follows:
tan .delta.=.sigma./.omega..di-elect cons.
[0091] where .omega. is frequency, and
where .di-elect cons. is permittivity
[0092] For example, at 5.8 Ghz, a range of conductivities .sigma.
suitable for use as the first bio-barrier component 52,
corresponding to a tan .delta. equal to or less than 0.1, would be
.sigma.=0.0 to 0.2 siemens/meter.
[0093] Another overlapping selection criteria for the first
bio-barrier component 52 is that the material, taking into account
its thickness, possesses requisite high thermal conductivity, to
efficiently allow thermal conduction to occur between the targeted
tissue region acquiring within the tissue acquisition chamber 42
and the cooling plate 28. For example, the material selected should
have a thermal conductivity of at least 0.1 watts per meter-Kelvin
(0.1 W/mK), and desirably 0.1 to 0.6 W/mK, and most desirably 0.25
to 0.45 W/mK.
[0094] Another overlapping selection criteria for the first
bio-barrier component 52 is that the material, taking into account
its thickness, possesses requisite high heat transfer coefficient.
The heat transfer coefficient can be expressed by the thermal
conductivity of the material divided by the thickness of the
material. For example, for a first bio-barrier component 52 with a
thermal conductivity of 0.1 and a thickness of 0.0005 inches, the
heat transfer coefficient would be about 7874 W/m2K.
[0095] Other overlapping selection criteria for the first
bio-barrier component 52 is that the material is sufficiently
flexible to conform to the surface of the cooling plate 28, while
also being sufficiently strong to resist tearing as a result of
vacuum pressure or contact with tissue.
[0096] In this respect, the first bio-barrier component 52 may be a
nonporous membrane, e.g., polyethylene film, nylon, or other
suitable materials. The first bio-barrier component 52 is desirably
flexible and soft for compliant contact with skin. The first
bio-barrier component 52 can comprise, e.g., polyethylene film
available from Fisher Scientific, or (alternatively) Mylar film.
The bio-barrier component 52 can be, e.g., about 0.0005 inch in
thickness.
[0097] The applicator-tissue interface body 92 also includes a
skirt 106 (see FIGS. 12A/B and 13) that depends downwardly with an
increasing diameter from the body about the periphery of the
applicator-tissue interface surface. The downward depending skirt
106 defines a generally funnel-shaped open interior area or chamber
leading to the first bio-barrier component 52 of the
applicator-tissue interface 16 (see FIG. 13). This chamber defines
the tissue acquisition chamber 42 previously described. The skirt
106 may comprise a compliant medical grade plastic material (e.g.,
a thermal plastic elastomer (TPE) such as urethane; or silicone; or
natural or synthetic rubber; or an elastomeric material) and may be
sized and configure to rest comfortably against an external skin
surface. When pressed with sufficient pressure to compress against
a tissue surface (see FIG. 21A), the periphery of the skirt 106
forms a generally fluid-tight, pressure-tight seal about the tissue
acquisition chamber 42.
[0098] The skirt 106 may include an alignment member 108 (see FIG.
5) positioned on each side of the skirt 106 to provide a
positioning point of reference to the caregiver during manipulation
of the interface, as will be described in greater detail later. The
funnel-shaped contour of the skirt 106 may provide a skirt angle
that gives the caregiver a direct view of the alignment members
108, while the caregiver manipulates the applicator-tissue
interface 16 attached to the system applicator 14.
[0099] As FIG. 12A shows, the vacuum supply conduit 44
communicating with the tissue acquisition function of the system
console 12 (see also FIG. 15) is coupled to a port formed on the
body of the applicator-tissue interface 16. The port communicates
with a vacuum channel 110 formed in the body (see FIGS. 12A and
12B) that communicates with the tissue acquisition chamber 42
adjacent the applicator-tissue interface surface. The vacuum
channel 110 may circumferentially encircle the tissue acquisition
channel at or near the applicator-tissue interface surface. The
vacuum channel 110 may include spaced-apart apertures or ports 82
formed along the vacuum channel (see FIG. 12B) (e.g., four ports,
one adjacent each side the applicator-tissue interface surface), to
convey negative pressure uniformly into the tissue acquisition
chamber 42 adjacent the applicator-tissue interface surface. The
ports 82 suction skin into the chamber and position the skin
against the first bio-barrier component 52 in thermal conductive
contact with the cooling plate 28 (as FIG. 21B shows).
[0100] The frame 102 and panels 104 of the tissue interface surface
100/52 may include formed apertures 112 (see FIG. 12A) that
register when assembled to form a vacuum balance path that
communicates with the tissue acquisition chamber 42. Negative
pressure applied in the chamber 42 is conveyed through the vacuum
balance path 112 to the opposite side of the interface surface
100/52 to equalize pressure on both sides of the interface surface
100/52.
[0101] A second bio-barrier component 54 of the multi-functional
bio-barrier 50 of the applicator-tissue interface 16 desirably
occupies the vacuum balance path 112. The second bio-barrier
component 54 in the vacuum balance path 112 (which can also be
called the "vacuum balance bio-barrier component") comprises a
material that is substantially impervious to liquid, but not to
air. The vacuum balance bio-barrier component 54 prevents
physiologic liquids such as blood and/or sweat that may be present
in the tissue acquisition chamber 42 from being transported through
the vacuum balance path 112 into the interior of the applicator 14.
Candidate materials for the second bio-barrier component 54 may
include pores sufficient to pass air (e.g., 0.45 .mu.m) to
substantially equalize the vacuum pressure on the system applicator
side and the interface side of the surface, without passing
biological liquids from the acquisition chamber 42 into the system
applicator 14. The second bio-barrier component 54 may comprise,
e.g., a hydrophobic membrane made from PTFE (Teflon) material. The
second bio-barrier component 54 can be, e.g., about 0.005 inch in
thickness.
[0102] The spaced-apart apertures or ports 82 formed along the
vacuum channel may include interior patterns 114 along its interior
that can impress a "hickey pattern" on the skin drawn into the
chamber 42 (see FIGS. 14A and 14B). The existence of "hickey
patterns" with the lesions can help guide the caregiver in
successive placements of the system applicator 14 to accurately
place a succession of lesions in the targeted tissue region.
Inconsistencies in the "hickey patterns" may also alert the
caregiver to gaps or inaccurately placed lesions in the lesion
pattern, to indicate a need to return and fill in gaps and missed
spots in the pattern. The interior patterns 114 define notches that
break surface contact and may help to prevent skin from blocking
the vacuum apertures or ports.
[0103] In a representative embodiment, the tissue acquisition
chamber 42 is dimensioned approximately 1.54 inches by
approximately 0.7 inches, having a depth (without the skirt 106) of
approximately 0.177 inch (4.5 mm). With the skirt 106, the depth of
tissue acquisition chamber 42 can be between approximately 6.5 mm
to 11 mm, depending upon the extent to which the compliant skirt
106 is compressed against the skin by the application of vacuum.
According to an embodiment of the invention the four corners of the
tissue acquisition chamber 42 may have a radius of 0.1875
inches.
[0104] In this arrangement, the waveguide antenna array 22 on the
opposite side of the tissue interface surface 100/52 include four
antennas 24 and possesses dimensions of approximately 1.34 inches
by approximately 0.628 inches. The dimensions of the waveguide
antenna array 22 and the tissue acquisition chamber 42 are
desirably optimized to minimize stray fields forming at the edges
of waveguide antenna array 22, as well as optimizing the effective
cooling area of the tissue interface surface. The tissue
acquisition chamber 42 is desirably optimized to facilitate tissue
acquisition without adversely impacting cooling or energy
transmission.
[0105] The vacuum supply conduit 44 may collect liquids (e.g.,
sweat or blood) that escape during the treatment process. For this
reason, a third bio-barrier component 56 of the multi-functional
bio-barrier 50 of the applicator-tissue interface 16 is placed
upstream of the applicator-tissue interface 16 in-line in the
vacuum supply conduit 44 (see FIG. 15, as is also generally shown
in FIG. 1). The third bio-barrier component 56 is selected to be
substantially impervious to liquid, but not to air. The third
bio-barrier component 56 can comprise, e.g., a hydrophobic filter
(e.g., a Millex FH filter made of 0.45 .mu.m hydrophobic PTFE
available from Millipore) to keep liquids out of the system console
12. The hydrophobic filter can be further characterized, e.g., by
accommodating an airflow of approximately 13.4 cubic feet per
minute at approximately 10 pounds per square inch.
[0106] The third bio-barrier component 56 can, alternatively,
comprise an in-line vacuum trap, as shown in FIGS. 16C and 16D. The
vacuum trap may include a formed housing 116 defining a vacuum
inlet port 118 (with which the vacuum supply conduit 44
communicates) and a vacuum outlet port 120 (which plugs into the
connection site 48 on the console 12). The housing 116 defines an
interior chamber 122, which the vacuum flow between the inlet and
outlet ports 118 and 120 must traverse from the applicator-tissue
interface 16 to the system console 12. A central ridge 124 on the
exterior of the housing 116 may provide a gripping surface for the
caregiver to hold and manipulate the vacuum trap, e.g., while
plugging the vacuum supply connector 118 into and out of the mating
console vacuum supply receptacle 48.
[0107] The chamber 122 is compartmentalized by an interior wall 126
into an inlet side 128, communicating with the inlet port 118, and
an outlet side 130, communicating with the outlet port 120. One or
more apertures 132 in the interior wall 130 define path(s) of flow
communication between the inlet and outlet sides 1w28 and 130 of
the chamber 122.
[0108] Baffle plates 134 interfere with vacuum flow through the
aperture(s) 132 through the interior wall 16 between the inlet side
128 and outlet side 130 of the chamber 122. The vacuum flow must
veer around the baffle plates 134 to transit through the chamber
122. An array of annular baffles 136 is further circumferentially
placed around the inlet side 128 of the chamber 122. The baffle
plates 134 and annular baffles 136 form an array of tortuous paths,
through which vacuum flow transiting the chamber must navigate. Air
in the vacuum flow will readily change direction to navigate the
tortuous paths. Physiologic liquid carried by the vacuum flow will
not, and will instead be captured by gravity in the nooks and
crannies of the tortuous paths through the chamber 122. The vacuum
trap thereby prevents physiologic liquid from passing out of the
outlet port 120 into the console 12.
[0109] 2. The Lesion Creation Function
[0110] As will be described in greater detail later, the microwave
signal applied through the waveguide antennas 24 to tissue acquired
within the tissue acquisition chamber 42 creates lesions in the
targeted tissue region, as generally shown in FIG. 23B. In the
treatment of hyperhidrosis, the lesions may be formed in the lower
dermis and/or dermis/hypodermis of the skin. Components carried
on-board the system console 12 control the microwave switch 26
carried on-board the applicator 14 to sequence the application of
the microwave signal by the waveguide antennas 24 in prescribed
manners to form the lesions in selected patterns, as FIG. 23B
illustrates. The patterns are selected to be conducive to achieving
the therapeutic objectives of the system 10.
[0111] (iv) The Lesion Control Function
[0112] Components carried on-board the system console 12 (see FIG.
15) generate and circulate cooling fluid through coolant paths
between the waveguide antenna array 22 and tissue cooling plate 28
carried in the system applicator 14, as is generally shown in FIGS.
10 and 11). The tissue cooling plate 28 protects skin engaged with
the applicator-tissue interface 16 (see FIG. 21B) from thermal
damage by preventing lesions formed in the dermis/hyperdermis from
expanding toward the epidermis.
[0113] The cooling fluid may comprise, e.g., water, de-ionized
water, or other suitable fluid.
[0114] The lesion control function can be accomplished in various
ways. In the illustrated embodiment (see FIG. 15), the lesion
control function includes a Peltier-effect thermoelectric cooler
(TEC) 138. As FIG. 15 shows, the TEC 138 receives power through the
power supply and power printed circuit board carried on-board the
system console 12, as do intake fans and chiller fans 140 that
circulate air within the console 12 for conveying from the console
12 heat generated by the components, including the TEC 138. The TEC
138 chills coolant in a reservoir 142 on-board the console 12. A
water pump 144 (also drawing power via the power printed circuit)
conveys chilled coolant from the reservoir 142. The chilled coolant
is circulated by a coolant supply line 146 through coolant paths
148 (see FIGS. 10 and 11) in the waveguide antenna cradle 72 and
between the waveguide antenna array 22 and tissue cooling plate 28
carried in the system applicator 14. Coolant is returned by a
coolant return line 150 to the reservoir 142. The coolant supply
and return lines 146 and 150 extend through the special purpose
cable assembly 34 (see FIGS. 16A and 16B) to the applicator 14. A
cooling fluid germicidal lamp 152 (e.g., 253.7 nm) may be provided
to prevent growth of microorganisms contaminants in the coolant
that could clog the fluid lines and reduce coolant flow in the
applicator 12. The cooling fluid germicidal lamp 152 may be
activated periodically, e.g., for a period of time (e.g., 10
minutes) following each power-on cycle or each coolant refill.
[0115] As FIG. 15 shows, the TEC 138 may be coupled to and
controlled by the master controller 58, so that its operation (like
that of the components of the tissue acquisition function) can be
coordinated by the master controller 58 with the generation and
application of microwave energy.
[0116] In the illustrated embodiment, the cooling plate 28 rests
against the terminal surfaces of the scattering elements 78 (see
FIGS. 10 and 11), but, in an alternate embodiment, the terminal
surfaces of the scattering elements can be spaced out of contact
with the cooling plate 28. Cooling paths 148 for the waveguide
antenna array 22 are formed in the spaces between the cooling plate
28 and each waveguide antenna 24, into which the scattering
elements 78 project. Coolant is circulated through these paths 148,
cooling each waveguide antenna 24 individually and the cooling
plate 28 in general.
[0117] The flow rate of coolant through these paths 148 can be,
e.g., approximately 425 milliliters per minute +/-45 milliliters
per minute. Desirably, the paths 148 are sized and configured so
that the flow rate of coolant along each waveguide antenna 24 is
substantially the same. The temperature of the coolant can be,
e.g., between approximately 8 degrees centigrade and approximately
22 degrees centigrade, and preferably approximately 15 degrees
centigrade.
[0118] The scattering elements 78 may extend into at least a
portion of coolant paths 148. It is desirable that the cooling
paths 148 be smoothed or rounded or shaped in the manner shown in
FIGS. 9, 10, and 11 to reduce the generation and/or build-up of air
bubbles in the paths 148. The scattering elements 78, for example,
may be formed in the shape of ovals or racetracks or oblong
hexagons with "faceted" or tapering ends (see FIGS. 9 to 11).
Hydrophilic coatings may be used on some or all of the cooling
paths 148 to, e.g., reduce the formation of bubbles.
[0119] The intermediate scattering elements 80 associated with the
waveguide antenna array 22 may also be located in the coolant paths
148 between the antenna apertures. In this arrangement, the
intermediate scattering elements 80 may be positioned such that
they facilitate equalized cooling across the cooling plate 28,
keeping in mind, however, that their principal function is to
influence lesion size and shape in, for example, the phase drive
mode. The intermediate scattering elements 80 may be sized such
that they have a width which is not more than slightly wider than
the separation distance between apertures of the waveguide antennas
24, so that they do not substantially interfere with the radiated
energy. The intermediate scattering elements 80, which extend into
coolant paths 148, may likewise be smoothed or rounded or shaped in
the manner shown in FIGS. 9, 10, and 11 to prevent the generation
and/or buildup of bubbles in the paths. The intermediate scattering
elements 80, for example, may be formed in the shape of ovals or
racetracks or oblong hexagons with "faceted" or tapering ends (see
FIGS. 9 to 11), provided that they are sized and configured to
modify and/or spread out a microwave field as it travels through
the coolant path 148. In this arrangement, the intermediate
scattering elements 80 (and the scattering elements 78) are
desirably made of materials which will not rust or degrade upon
exposure to the coolant.
[0120] Likewise, the cooling plate 28 may be laser cut (with a
thickness, e.g., of about 0.020 inch) with curved corners.
[0121] Thermocouples 154 may be placed on the surface of the
cooling plate 28 opposite to the cooling path 148 (see FIGS. 10 and
11), generally aligned with and between the apertures of the
waveguide antennas 24. The thermocouples 154 can, if desired, be
printed (sputtered) on the cooling plate 28. The thermocouples 154
can, e.g., comprise a plurality of T-type thermocouples (e.g.,
seven) masked and sputtered with varying alloy compositions of
copper and nickel, e.g., constantan, such as, e.g., 60% copper/40%
nickel, and then re-masked and sputtered with copper such that the
copper and the copper-nickel components form a junction that serves
as a thermocouple. One or more thermocouples 154 may also be placed
in the supply and return lines. The thermocouples 154 are coupled
to the applicator main board 60, which communicates sensed
temperature conditions through the special purpose cable assembly
34 to the master controller 58 on board the system console 12. The
sensed temperature conditions are processed according to
preprogrammed logic residing in the master controller 58, as part
of the waveform generation function, and may be used to adjust
power supplied to the waveguide antennas 24 based upon temperature
conditions sensed along the cooling plate 28.
III. System Controllers
A. On Board the System Console
[0122] (The Master Controller)
[0123] The master controller 58 (see FIG. 15) resides on a control
printed circuit board in the system console 12. The master
controller 58 receives 12V power from the power supply. The master
controller 58 communicates with components carried by the system
console 12 as well as components carried by the applicator.
[0124] The special purpose cable assembly 38 (see FIGS. 1 and
16A/B) establishes a multi-purpose link between the master
controller 58 and the applicator 14. Extending through the special
purpose cable assembly (see FIGS. 16A and 16B) are the microwave
energy cable 68 for conveying the microwave signal from the
generator controlled by the master controller 58 to the microwave
switch 26 on the applicator 14; the coolant supply and return
conduits 146 and 150 for conveying coolant to and from the coolant
reservoir 142 for circulation through the coolant paths 148 of the
waveguide antenna array 22 and cooling plate 28 in the applicator;
and a connector 156 establishing communication links between the
master controller 58 and the applicator main control board 60
according to a prescribed communication protocol (e.g., the
CMX-RTX.TM. RTOS (embedded real-time operating system) Product
Line, available from CMX Systems, San Jose, Calif.). The bundling
of multiple electrical and fluid conduits through a single special
purpose cable assembly 34 serves to streamline the form and
function of the system 10 and simplify set up of the system 10,
while also efficiently supporting the diverse functions of the
system 10 itself, in terms of electrical waveform generation,
coolant circulation, and providing communication links. The
multi-special purpose cable assembly 34 facilitates lengthening the
cable (e.g., upwards to eight feet) for better reach and ease of
manipulation remote from the system console 12.
[0125] As shown in FIG. 15, communications between the master
controller 58 and components residing in or on the console 12 can
include (i) the colored (e.g., blue) LED on the console 12 that
indicates when the generator is applying microwave energy to the
targeted tissue region; (ii) the footswitch 32; (iii) the graphical
user interface screen; and (iv) a speaker to generate audible
alarms or status sounds. Also communicating with the master
controller 58 may be (v) a radio-frequency identification (RFID)
reader, which provokes signal transmission from passive RFID tags
158 carried by the applicator-tissue interface 16 or its packaging
(see FIG. 25) to identify the applicator-tissue interface 12 prior
to use, as will be described later. The RFID reader can also
function, if desired, to erase information carried by a RFID tag
158 after being read, e.g., to prevent reuse of a given
application-tissue interface 16 (alternatively, reading and
identification functions based upon bar-coded information may be
used); and (vi) a sensor 160 on the holster 20 that indicates when
an applicator resides on the holster 20.
[0126] Regarding the holster 20 (see FIG. 2), the holster 20 is
operative for storing the applicator on the system in two secure
positions: 1) facing "in," when the applicator-tissue interface 16
carried by the applicator faces toward a power absorber 168 carried
by the holster 20, in which the master controller 58 can execute a
"test" mode to verify the delivery of power, water temp sensor
response, antenna switching where the power is safely contained by
the power absorber 168, and 2) facing "out" away from the power
absorber 168 for easy access to the attachment point for the
applicator-tissue interface 16. When the applicator 14 is in the
holster 20, the "facing in" position information desirably verifies
that any power delivered during the "test mode" shall be safely
contained by the power absorber 168. The facing "in" position is
sensed by a magnetic sensor 160 on the holster 20 and a magnet 162
carried by the applicator that registers with the magnetic sensor
160 if and only if the applicator 14 and applicator-tissue
interface 16 is facing "in." The "facing out" position need not
necessarily be sensed.
[0127] Sensed operating conditions are also communicated to the
master controller 58. The sensed conditions may include (i) sensed
forward power signals detected by the microwave generator 66; (ii)
sensed reverse power detected directly by the master controller 58;
(iii) sensed negative pressure levels in the vacuum supply line 44,
which may be sensed both upstream and downstream of the vacuum
solenoid valve 90; (iv) sensed coolant flow in the coolant supply
line 146; (v) coolant level in the coolant reservoir 142; and (vi)
sensed temperature of the thermoelectric cooler (TEC 138). Other
sensed operating conditions that also may be communicated to the
master controller 58 by the applicator main board 60, e.g., (i)
sensed forward and reverse power signals detected onboard the
applicator 14; (ii) microwave switch status conditions; and (iii)
sensed temperature conditions processed by the main applicator
board from signals received by the thermocouples 154 residing on
the cooling plate 28 and coolant supply line 146 in the
applicator.
[0128] The master controller 58 also communicates energy generation
signals to the microwave generator 66, and operating signals to the
solenoid vacuum valve 90. Preprogrammed rules or logic on the
master controller 58 process sensed information communicated to the
master controller 58 to generate command signals and alarms when an
out of bounds condition exists. Based upon the processed
information, the master controller 58 may, e.g., increase or
decrease fan speeds to maintain the TEC 138 at a desired
temperature; increase or decrease coolant flow; or alter power
levels.
[0129] In a representative embodiment, the master controller 58
desirably is capable of supporting communication and control with
the applicator 14. The master controller 58 desirably receives from
the applicator information about the applicator temperatures,
antenna power and state of the "trigger" switch on the applicator.
The master controller 58 desirably sends to the applicator 14
information describing which antennae should be enabled. The master
controller 58 desirably sends to the applicator 14 commands to
control the applicator LED's, if any. The communication desirably
includes fault conditions detected in the applicator. The master
controller 58 is desirably capable of supporting the following
system states indicated on the applicator: Ready, Treatment,
Cooling and Fault.
[0130] The master controller 58 desirably serves to detect failures
or unexpected/out of tolerance behavior and react to minimize risk
of injury to the patient and, when possible, damage to the
device.
[0131] For example, a prescribed incremental loss of vacuum (e.g.,
more than 5 inches of Hg vacuum) may immediately pause the energy
delivery cycle. If the incremental loss persists for less than
prescribed period of time (e.g., less than 2 seconds), energy
delivery may resume when the vacuum level returns to the prescribed
level. If the incremental loss persists for longer than the
prescribed interval, the master controller 58 may abort the therapy
cycle and cause it to enter a post-cool phase.
[0132] For example, loss of communications to the applicator or the
generator may cause the master controller 58 to enter a safe state
by aborting the therapy cycle and causing it to enter the post-cool
phase by terminating energy delivery during loss of applicator
communications and disabling the amplifier (mute enabled) during
loss of amplifier communications.
[0133] For example, temperature monitoring at the applicator
cooling plate 28 may be used to detect treatment conditions. For
example, if the temperature exceeds a predetermined amount (e.g.,
40.degree. C.) within the first 2 seconds of energy delivery, the
master controller 58 may abort the therapy cycle and cause it to
enter the post-cool phase. If the temperature exceeds the
predetermined amount after the first 2 seconds of energy delivery,
the master controller 58 may immediately terminate energy delivery
to that antenna and initiate energy delivery to the next antenna in
the therapy sequence.
[0134] For example, vacuum pump drive may be monitored and compared
to nominal drive levels with tolerance bounds to make sure that
excessive vacuum leaks that could occur when the target tissue has
not been properly acquired or during loss of tissue acquisition are
properly reported to the caregiver through the user interface. If
the vacuum pump drive fluctuations are excessive during a therapy
cycle, the master controller 58 may abort the therapy cycle and
cause it to enter the post-cool phase.
[0135] For example, internal voltage monitoring of the power supply
voltage inside the generator and on the master controller 58 may be
used to determine if a fault condition exists that may abort the
therapy cycle and cause the system to enter the post-cool
phase.
[0136] For example, microwave power may be continuously monitored
in the console and at the applicator during energy delivery and
non-energy-delivery phases of the therapy cycle. During energy
delivery, the microwave power may be required to be within a
specified range and during the non-energy-delivery phases of
therapy it should be less than the specified threshold. If a fault
condition exists, the master controller 58 may abort the therapy
cycle and cause the system to enter the post-cool phase. If a fault
condition exists during the non-energy-delivery phases of therapy,
the generator may be disabled (mute enabled).
[0137] For example, internal temperatures of critical components
may be monitored for detection of excessive thermal conditions.
[0138] For example, if there are thermoelectric cooler errors,
temperature errors, flow rate errors, or water level errors during
a therapy cycle, the master controller 58 may abort the therapy
cycle and cause it to enter the post-cool phase.
[0139] The master controller 58 may provide the capability to store
data associated with each treatment cycle that the system performs.
This data may be stored in memory that is not erased when the power
to the system is removed or turned off. The information contained
in the data log may be made accessible through a service mode
screen on the graphical user interface 62. It may store some or all
of the following information for each applicator placement in a
treatment data log in a folder in system memory: (i) Date and Time;
(ii) Average forward power; (iii) Maximum reverse power (from the
master controller 58) and/or from each applicator detector board,
as will be described below); (iv) Temperature rise (delta) for each
of the temperature sensors located on the applicator cooling plate
28; (v) Maximum coolant temperature; and/or (vii) Fault Events and
associated Error codes.
B. On Board the Applicator
[0140] As best shown in FIGS. 7 and 8, a microwave switch 26 in the
applicator has an input coupled to the microwave energy supply
lead. The microwave switch 26 can comprise, e.g., a switch
manufactured by Relcom Technologies, Inc., Part No. RMT-SR019.
Individual feed connector cables 70 may lead from outputs of the
switch 26 to individual detector boards 170, which include
directional couplers (see FIG. 17) to pass the microwave signal to
the waveguide antennas 24, as well as couple the signal to forward
and reverse power detection circuitry.
[0141] The master controller 58 on-board the system console 12
includes imbedded pre-programmed rules establishing the desired
switching patterns for applying the microwave signal through the
waveguide antennas 24. The signals from the master controller 58
are converted by the applicator main board into switching signals
which, in turn, control the operation of the switch to execute
these patterns.
[0142] 1. Localized Forward and Reverse Power
[0143] Detection
[0144] As just stated, forward and reverse power signals are
detected by the master controller 58 as the microwave signal is
transmitted through the special purpose cable assembly to the
system applicator 14. These forward and reverse power signals,
local to the console 12, are communicated to the master controller
58 for power control purposes.
[0145] In addition, the system applicator 14 may carry additional
on-board a detector board circuit (see FIGS. 17 and 18) for
detecting forward and reverse power locally on the applicator.
These forward and reverse power signals, local to the applicator
14, are communicated by the applicator main board 60 to the master
controller 58 on-board the console 12 for processing as further
confirmation that power settings are within prescribed bounds.
[0146] As shown in FIG. 7, the detector board circuit comprises
four detector boards 170, a given detector being electrically
coupled and dedicated to a single waveguide antenna 24. The
electrical configuration of each detector board 170 is essentially
the same, as will now be described.
[0147] (a) Directional Coupler
[0148] FIG. 17 shows the circuit traced on each detector board. The
circuit includes directional coupler (also shown in FIG. 18) having
a thru line and a coupled line (which have been generally described
previously). The thru line has an input that receives the microwave
signal, as switched to the individual waveguide antenna 24 by the
system applicator main board 60, and an output that conveys the
received microwave signal to the respective waveguide antenna 24.
As best shown in FIG. 18, the coupled line runs in proximity to the
thru line for a fixed distance, to allow a sample of energy
travelling through the thru line to be transferred into the coupled
line. The coupled line is directional, meaning that it samples the
forward power on one port of the coupled line and the reflected
power on the other port. The length of the coupled section, the
distance between the thru and coupled lines, the optimization of
coaxial feeds to efficiently transfer power, the mountings, and the
way in which the ports of the coupler are terminated determine the
amount of power sampled in the forward and reflected ports and the
isolation between the two ports.
[0149] In the illustrated embodiment (see FIG. 18), the directional
coupler circuit is implemented using asymmetric stripline
transmission lines (a stripline in which the center conductor is
not equidistant from the upper and lower ground planes). Energy is
fed into the input port and out of the output port through the
ground plane which is closer to the center conductor of the
stripline. The forward and reverse sampling ports include a
transition from asymmetric stripline to microstrip line. This
allows for easy placement and assembly of the discrete components
of the detector circuit.
[0150] (b) Attenuator and DC Blocking Circuit
[0151] The forward and reverse sampled power ports feed microwave
energy into a microwave attenuator and DC blocking circuit as shown
in FIG. 17. The microwave attenuator circuit serves to condition
the amount of microwave power to an optimal range of levels for the
power detector. The circuit also includes a DC block such that no
low-frequency signals can travel from the power detector or signal
conditioning circuitry down the high frequency microwave path.
[0152] (c) Power Detector
[0153] The circuit (see FIG. 17) includes a reverse power detector
and a forward power detector. The power detectors convert the
high-frequency microwave signal to a low-frequency AC or DC signal.
The converted low-frequency signal has a strength that is directly
proportional to or indicative of the strength of the input
high-frequency signal. The detectors can comprise, e.g., an
ADL-5510 Detector IC (available from Analog Devices), or another
active/passive detection device.
[0154] (d) Signal Conditioning Circuitry
[0155] The circuit (see FIG. 17) includes signal conditioning
circuitry for each forward and reverse power detector. The signal
conditioning circuitry performs three main functions. It provides a
clean (non-noisy) supply voltage to the power detector and any
other active components. It filters out any unwanted internal or
external noise in the detector circuit. Finally, it serves as a
low-pass filter for the low-frequency output of the power detector.
This reduces any low-frequency AC signal coming out of the power
detector (i.e. as a result of a pulse-width modulated microwave
signals) to a DC signal for subsequent digitization on the
applicator main board and transmission back to the master
controller 58 onboard the console 12.
[0156] 2. Temperature Sensing
[0157] The temperature condition measurements from the
thermocouples 154 along the cooling paths and at the tissue cooling
plate 28 are also communicated by the system applicator main board
to the master controller 58 of the system console 12 via the
connection links 156 through the special purpose cable assembly 34.
Based upon this closed loop feedback, the logic residing in the
master controller 58 may control power as part of the energy
generation function.
[0158] 3. The LED Indicator Board
[0159] In the illustrated embodiment (see FIGS. 7 and 19A/B/C/D),
the LED indicator board 172 includes an appropriate number of LED's
and/or lightpipes 174 that are arranged on a display area visible
to the caregiver on the housing adjacent the switch 30.
[0160] In a representative embodiment, there are 15 LED's and 7
lightpipes. The system applicator main board 60 communicates sensed
status and operational information from the master controller 58 to
the LED indicator board 172. The LED indicator board 172, in turn,
commands operation the LED's and/or lightpipes 174 according to
pre-programmed rules in term of the display of colors and/or light
patterns and/or backlighting colors and patterns, to visually
communicate these status and operational conditions to the
caregiver.
[0161] The presence of desired operating conditions and out of
bounds conditions can be visually represented by different
backlighting colors, as can the status of a treatment cycle. The
nature and content of information visually communicated by the LED
indicator board can be widely varied and tailored to the needs of
the individual system 10.
[0162] For example, LED's can be backlighted indicating the status
of operations (see FIG. 19B); for example, a green backlight may
indicate a system ready condition; a blue backlight may indicate
when energy is being applied to tissue; and a red backlight may
indicate a fault or error condition. LED's may be sequentially
illuminated to indicate the status of treatment, e.g., a single LED
to indicate the initiation of treatment (see FIG. 19C), all LED's
illuminated indicating the end of treatment (see FIG. 19E); and
intermediate numbers of LED's being illuminated as treatment
proceeds (see FIG. 19D).
C. Conclusion
[0163] In the representative embodiments, decision making function
of the system applicator main board 60 may be extensive or
purposely limited. In the illustrated embodiment, the
pre-programmed rules residing on the system applicator main board
60 may switch the microwave switch 26 and LED's 174. The system
applicator main board 60 may communicate to the master controller
58 any detected error, the status of the power switch on the system
applicator 14, LED's and microwave switch 26 positions, sensed
temperature conditions, and measured forward and reverse power. The
master controller 58 on-board the system console 12 may make all
other control decisions based upon these data.
III. Use of the System
[0164] A. Anatomy of the Skin
[0165] FIG. 20 shows an idealized and simplified anatomic schematic
drawing of the human skin--the body's largest organ--and its
structures. FIG. 20 shows in idealized and simplified form the
layered arrangement of the body's covering and the hairs and glands
embedded within the skin and subcutaneous tissue.
[0166] The skin consists of the epidermis (a superficial cellular
layer) and the dermis (a deeper connective tissue layer). The
subcutaneous tissue below the dermis (the hypodermis) is composed
of loose, fatty connective tissue. Located between the dermis and
the underlying deep fascia, the hypodermis contains hair follicles,
sweat glands, blood vessels, lymphatics, and cutaneous nerves.
[0167] As shown in idealized and simplified form in FIG. 20, the
interface between the dermis and the hypodermis typically is
non-linear and non-continuous, comprising an irregular interface,
which may also include many tissue structures or groups of tissue
structures which cross and interrupt the tissue interface.
[0168] The deep fascia is a dense, organized connective tissue
layer below the hypodermis that invests deep structures such as the
muscles.
[0169] The deep dermis and hypodermis may contain hair follicles
with their associated smooth arrector pili muscles (which contact
to cause "goose bumps") and sebaceous glands (which, when
compressed by contraction of the arrector pili muscles, express
their oily secretion onto the skin surface).
[0170] The deep dermis and hypodermis may also contain a larger
number of sweat glands. Apocrine sweat glands produce a complex
secretion that may generate a strong odor and are numerous in
certain areas of the body, such as under the arms and in the
genital region. Eccrine sweat glands are also generally distributed
throughout the entire hypodermis, and are numerous in the palms of
the hands, soles of the feet, and axilla.
[0171] The sweat glands produce perspiration in response to
stimuli, including emotional stimulation and to adjust body
temperature. Some people sweat more in warm temperatures, when they
exercise, or in response to situations that make them nervous,
angry, embarrassed, or afraid.
[0172] B. Application of Microwave Energy to the Skin Using the
System
[0173] In use, the system 10 may apply microwave energy to the
skin, e.g., to treat hyperhidrosis. To set up for use (as FIG. 1
generally shows), an unused applicator-tissue interface 16 is
joined to the system applicator 14. The vacuum supply conduit 44
can be carried in a recess in the pistol grip of the system
applicator 14, to run along the special purpose cable assembly 34
for coupling to a vacuum connection port 48 on the system console
12. The special purpose cable assembly 34 is likewise coupled to
the special purpose connector 38 on the system console 12, coupling
the system applicator 14 to the system console 12. The main power
switch of the system console 12 is turned on, and the master
controller 58 of the system console 12 executes a start-up and
initialization routine. The caregiver sets the commanded power and
vacuum conditions. The master controller 58 initiates a constant
circulation of coolant through the system applicator 14.
[0174] After identifying the tissue region to be treated, the
caregiver places the compliant skirt 106 of the interface body
against skin in the targeted tissue region (as shown in FIG. 21A).
The edges of the compliant skirt 106 form a seal against the skin.
The caregiver actuates the external power switch on the housing.
The system console 12 supplies negative pressure through the vacuum
supply conduit 44 into the chamber 42. The negative pressure in the
chamber 42 serves to draw tissue into the chamber 42 (i.e., elevate
the tissue) into contact with the applicator-tissue interface
surface 100/52 in thermal contact with a least a portion of the
cooling plate 28 (as shown in FIG. 21B). The vacuum within the
tissue acquisition chamber 42 elevates the dermis and hypodermis,
separating dermis and hypodermis from muscle. The vacuum within the
tissue acquisition chamber 42 localizes and stabilizes the tissue
region within the chamber 42. By separating the dermis and
hypodermis from muscle, the vacuum within the tissue acquisition
chamber 42 serves to protect muscle by limiting or eliminating the
electromagnetic energy that reaches muscle. The vacuum is applied
until a desired vacuum condition and/or tissue temperature
condition is achieved. Alternatively, a delay period for a
prescribed interval of time can occur.
[0175] Once the desired vacuum and/or temperature condition is
sensed (or after a prescribed delay, if relied upon), the system
console 12 supplies the microwave signal to the system applicator
14. The microwave signal generated by the system console 12 is
applied in a predetermined manner to the tissue region. Its
electromagnetic radiation may be radiated at a frequency of, for
example, between 5 and 6.5 GHz, or at a frequency within that range
of about 5.8 GHz, at a power entering an individual antenna of
between 20 to 60 W, desirable between 25 and 45 W, more desirably
between 32 to 38 W, and most desirably 35 W. It should be
appreciated that, if power is measured leaving the generator, the
power magnitudes expressed above will be greater due to power loses
through cables and other power losses between the generator and the
antenna. For a relatively short cable, a power of 55 W measured at
the generator will likely yield the desired power range at the
antenna. For longer cables, the power measured at the generator
must be increased (e.g., up to 65 W) to achieve the desired range
of power levels at the antenna.
[0176] The microwave power may be applied in succession to
individual antenna, e.g., in the progression antenna A, then
antenna B, then antenna C, and then antenna D, or antenna A, then
antenna C, then antenna B, and then antenna D. The microwave may be
applied in prescribed time increments at each antenna, e.g.,
antenna A (3 seconds), antenna C (3 seconds), antenna B (3
seconds), and antenna D (3 seconds), followed by a post-cooling
interval based upon time (e.g., 20 seconds), then followed by a
release of vacuum pressure.
[0177] The microwave power may, alternatively, be applied to both
individual antennas and split between pairs of antennas in phase
drive mode, as will be described in greater detail later. The
sequence can comprise, e.g., antenna A (2.5 seconds), then antennas
A-B (2.5 seconds); then antenna B (2.5 seconds), then antenna B-C
(2.5 seconds), and so on, followed by a post-cooling interval based
upon time (e.g., 20 seconds), then followed by a release of vacuum
pressure.
[0178] C. Creation of Lesion Patterns
[0179] Components carried on-board the system console 12 (see FIG.
15) apply the microwave signal through the waveguide antennas 24 to
tissue acquired within the tissue acquisition chamber 42 to carry
out the lesion creation function.
[0180] The microwave signal may be applied, for example, in
succession by each waveguide antenna. Alternatively, the microwave
signal may be applied in succession by a single waveguide antenna
(A), then concurrently by the single waveguide antenna and the next
adjacent waveguide antenna (AB) with the microwave power applied to
adjacent antennas 24 in phase (i.e., such that the energy applied
results in constructive wave interference between the radiated
energy from each antenna at the targeted region), and then by the
next adjacent waveguide antenna (B) alone, and then by the
waveguide antenna (B) and its next adjacent antenna (C) (i.e., BC)
with the microwave power applied to adjacent antennas 24 in phase
(i.e., such that the energy applied results in constructive wave
interference between the radiated energy from each antenna at the
targeted region), and so on in succession C-CD-D until all
waveguide antennas 24 have been involved (which in shorthand is
called a phase-driven mode).
[0181] When pairs of antennas are switched to simultaneously
radiate energy, field interference patterns are created due to two
phenomena: (i) "standing wave" interaction between forward
travelling waves propagating through the epidermis/dermis and
reverse travelling waves reflected off of the dermal/hypodermal
boundary, as well as (ii) "phase" interaction between the signals
radiated by each antenna.
[0182] First, interactions occur when energy radiated by the two
antennas propagates through the epidermis/dermis and then reflects
off of the dermal/hypodermal interface back into the dermis. A
standing wave pattern is created where the forward and reflected
signals generate an interference pattern that varies primarily in
the direction perpendicular to the tissue planes (i.e. varies with
depth in tissue). The wavelength (and correspondingly the
frequency) of the radiated signal determines the regions in which
the standing wave pattern is constructive and destructive. An
"optimal standing wave interference pattern" is created by choosing
a frequency (e.g. 5.8 GHz) such that constructive interference
occurs in the deep dermal region and is minimized in the shallower
dermal and epidermal region.
[0183] Second, interactions occur when energy radiated by each
antenna interfere with each other. An antenna interference pattern
is created where the differences in the phase of the radiated
energy from each antenna determine regions where the individually
radiated signals add constructively or destructively. The variation
of the interference pattern with phase occurs primarily in the
direction parallel to the tissue planes. An "optimal antenna
interference pattern" is created by choosing a phase relationship
between the two antennas such that constructive interference occurs
in the region between the two antennas and destructive interference
occurs in the region underneath each individual antenna. A phase
difference of 0 degrees (i.e., "in-phase") between radiated signals
from the antennas is the optimal phase relationship for achieving
the "optimal antenna interference pattern."
[0184] To achieve this phase relationship, phase-balanced
interconnecting cables can be utilized to connect antennas with the
same feed direction (e.g., antennas A and B). Similarly,
interconnecting cables with a 180 degree phase difference should be
utilized to connect antennas with opposite feed directions (e.g.,
antennas B and C).
[0185] In phase-driven mode, when two antennas radiate energy
concurrently, the energy has the same frequency and the antennas
are driven in phase. The power provided from the generator to the
microwave switch is split between the two antennas such that each
radiates on-half of the supplied power. The overall interference
pattern in tissue is optimal in terms of both the standing wave
interference pattern and the antenna interference pattern. This
occurs since the two interference phenomena are largely
independent, with the standing wave interference occurring in the
perpendicular direction and the antenna interference occurring in
the parallel direction. As a result, an overall interference
pattern that is constructive in the deep dermal region between the
two antennas and is destructive in the shallow dermal/epidermal
region and in the region underneath individual antennas is
achieved.
[0186] If applied by an individual waveguide antenna at a given
frequency and power level (see FIG. 22A), a first region of peak
tissue effect initiates generally beneath the scattering element 78
of the waveguide antenna and in the deep dermis (above the
interface between the dermis and hypodermis). This is the result of
the "optimal standing wave pattern` creating a maximum power
absorption in the deep dermis in the region where constructive
interference occurs.
[0187] If applied concurrently through two adjacent waveguide
antennas 24 at the same frequency and in phase, and at a total
power from the generator that is split equally between the antennas
24 (see FIG. 23A), a first region of peak tissue effect initiates
generally between the scattering elements 78 of the waveguide
antennas 24 above the interface between the dermis and hypodermis.
This constitutes the desired concurrent effect of both standing
wave interference pattern and antenna interference pattern. The
standing wave interference pattern initiates in the region of peak
tissue temperature generally above the interface between the dermis
and hypodermis, just as when energy of the same frequency is
applied by an individual waveguide antenna. The antenna
interference pattern initiates in the region of the first region of
peak tissue effect generally within the same tissue plane, but
between the scattering elements 78 of the waveguide antennas 24 and
at generally the same power level as when energy is applied by an
individual waveguide antenna (the power that has been divided in
half and fed into each antenna 24 is recombined in tissue).
[0188] The peak tissue effect can be expressed, e.g., in terms of
peak Specific Absorption Rate (SAR), which is a measure of the rate
at which the energy is absorbed by tissue (in terms of power
absorbed per mass of tissue in units of watts per kilogram).
Alternatively, the peak tissue effect can be expressed as, e.g.,
peak power loss density, or a peak tissue temperature. (as FIGS.
24A and 25A show), the first region of peak tissue effect initiates
in the dermis generally above the interface between the dermis and
hypodermis, due to a standing wave effect the interface imposes
upon the microwave signal in the dermis. The interface reflects
electromagnetic waves radiated by the waveguide antenna to cause
constructive wave interference above the interface, initiating the
peak tissue effect.
[0189] As FIGS. 22A and 23A show, successive second, third, and
fourth regions of tissue effects are observed to spread from the
first region due to conductive/convective heating effects with
reduced tissue effect magnitudes at increasing radial distances
from the first region. These "ripple" regions of diminishing tissue
effects extend toward the epidermis and, in part, can extend below
the interface into the hypodermis, as FIGS. 22A and 23A show.
[0190] The tissue effects serve to create a localized lesion in the
first tissue region within the dermis (see FIGS. 22B and 23B). The
localized heating effect in the dermis can, by resulting
conductive/convective heating effects, damage or destroy structures
in the dermis and/or hypodermis, such as, for example, sweat glands
in the skin of an individual undergoing treatment.
[0191] The scattering element 78 and intermediate scattering
elements 80 may be used, for example, to spread and flatten the
first region of peak tissue effect in terms of peak SAR, and/or
peak power loss density, and/or peak tissue temperature. The
scattering element 78 and intermediate scattering elements 80 can
thereby serve to spread and flatten the lesion formed in first
tissue region to further control the localized effects. The
temperature conditions established by the cooling plate 28 keep the
lesion from expanding toward the epidermis.
[0192] By programming the master controller 58 to switch the
waveguide antennas 24 in a predetermined pattern, the microwave
signal generated by the system console 12 can be applied to the
skin to form complex patterns of lesions. For example, as shown in
FIG. 23B, lesions may be created in a predetermined order, such as,
for example A-B-C-D, where: A represents a lesion initiated
directly under waveguide antenna A; B represents a lesion initiated
directly under waveguide antenna B; C represents a lesion initiated
directly under waveguide antenna C; and D represents a lesion
initiated directly under waveguide antenna D. Overlapping lesions
can be formed in the tissue intervals between lesions A-B-C-D by
creating lesions in a predetermined order, for example,
A-AB-B-BC-C-CD-D where: A represents a lesion initiated directly
under waveguide antenna A; AB represents a lesion initiated under
the intersection between waveguide antenna A and waveguide antenna
B; B represents a lesion initiated directly under waveguide antenna
B; BC represents a lesion initiated under the intersection between
waveguide antenna B and waveguide antenna C; C represents a lesion
initiated directly under waveguide antenna C; CD represents a
lesion initiated under the intersection between waveguide antenna C
and waveguide antenna D; and D represents a lesion initiated
directly under waveguide antenna D. A lesion AB may be created
between waveguide antenna A and waveguide antenna B, by driving
waveguide antenna A and waveguide antenna B simultaneously in phase
and with a balanced output from each antenna. A lesion BC may be
created between waveguide antenna B and waveguide antenna C, by
driving waveguide antenna B and waveguide antenna C simultaneously
in phase and with a balanced output from each waveguide antenna. A
lesion CD may be created between waveguide antenna C and waveguide
antenna D, by driving waveguide antenna C and waveguide antenna D
simultaneously in phase and with a balanced output from each
waveguide antenna.
[0193] It should be appreciated that power can be applied
homogenously, with the same power and time increments for each
antenna or each pair of antennas 24 (in phase drive mode). Power
can also be applied differently among different antennas 24 or
pairs of antennas 24. Power can be changed for different antennas
24 or pairs of antennas 24, and/or time can be varied for different
antennas 24 or pairs of antennas 24. Thus, the energy delivered to
a given tissue region (energy being the product of power and time)
can be varied from tissue region to tissue region being
treated.
[0194] 1. The Treatment Template
[0195] The system 10 may further include a treatment template 176
(see FIGS. 23A and 23B) to provide guidance and placement
information for system applicator 14 in a matrix format. The
treatment template 176 is sized and configured to overlay an entire
axilla (underarm) tissue region targeted for treatment. The
template 176 can comprise a temporary tattoo applied to each
underarm (left side as shown in FIG. 24A and right side and shown
in FIG. 24B). Alternatively, the template 176 can comprise a
pattern applied by stamping on a tissue region. The template 176
can comprise an overlay stencil placed on the skin surface and
applied by a marker pen through the stencil. The template 176 can
comprise an overlay mesh sticker applied to the tissue region.
[0196] A family of templates 176 (see FIG. 25) can be provided,
with different sizes and arrays, to accommodate the different
anatomies of individuals.
[0197] The template 176 may include prescribed anesthesia injection
sites (small thru holes) to identify appropriate points in the
axilla for the injection of anesthesia; and device alignment points
in an x-y matrix axis (1A to 10A and 1B to 10B, and more depending
upon the size of the axilla) to be used in conjunction with
alignment members 108 on the compliant skirt 106 to provide a
positioning point of reference to the caregiver during use of the
template 176.
IV. Instructions for Use
[0198] As FIG. 25 shows, the system applicator 14 and/or
applicator-tissue interface 16 of the system 10 can be provided for
use in sterile kits 180. In the illustrated embodiment, each kit
180 includes an interior tray 182 made, e.g., from die cut
cardboard, plastic sheet, or thermo-formed plastic material. The
system applicator 14 and applicator-tissue interface 16 is carried
by a respective tray 182. Either kit 180 can also include in the
tray or separately packaged a treatment template or family of
templates 176.
[0199] Each tray 182 may include a tear-away overwrap, to
peripherally seal the tray from contact with the outside
environment. Each kit 182 carrying the system applicator 14 and/or
applicator-tissue interface 16 may be sterilized by convention
ethylene oxide (ETO) sterilization techniques. In the illustrated
embodiment, the packaging for one or both the system applicator 14
and/or applicator-tissue interface 16 can carry passive RFID tags
158 that interact with radio-frequency identification (RFID) source
on the console 12 (shown in FIG. 15).
[0200] In the illustrated embodiment, one or both kits 180 also
preferably include directions or instructions for using 184 the
system applicator 14 and applicator-tissue interface 16 in
conjunction with the system console 12 to carry out a desired
procedure. Exemplary directions will be described later. The
directions or instructions 184 can, of course vary, according to
the particularities of the desired procedure. Furthermore, the
directions or instructions 184 need not be physically present in
the kit. The directions or instructions 184 can be embodied in
separate instruction manuals, or in video or audio tapes, or in
electronic form. The instructions or directions can also be
incorporated into a graphical user interface, as will be
demonstrated later.
[0201] Representative instructions 184 direct use the
applicator-tissue interface 16 in concert with the system
applicator 14 and system console 12 to apply microwave energy to
the skin, e.g., to treat hyperhidrosis. These instructions 184 can
also be reflected on the graphical user interface 62, as will now
be described.
V. Graphical User Interface
[0202] The master controller 58 of the system console 12 can
includes circuitry to implement a graphical user interface 62 on
the display screen 64, as generally shown in FIG. 11. The graphical
user interface 62 can provide control and alarm conditions to the
caregiver, and allow for touch-screen interaction and input from
the caregiver to the master controller 58.
[0203] A representative screen for a graphical user interface 62 is
shown in FIG. 26. The logic and flow of a representative graphical
user interface 62 are shown schematically in FIGS. 37 to 31 with
reference to representative graphical screen prompts in FIGS. 32 to
59.
[0204] As FIG. 27 shows, the logic and flow of the graphical user
interface 62 begins with a start-up routine after power to console
is turned on. The master controller 58 determines whether the
special purpose cable is plugged in (see prompt in FIG. 32) and
then proceeds through a self-test routine (see FIG. 33). If the
applicator is not facing "in" on the holster 20, the caregiver is
instructed to position the applicator correctly (see FIG. 34). A
welcome screen confirms that no errors are detected (see FIG.
35).
[0205] As FIG. 28 shows, the logic and flow of the graphical user
interface 62 next instructs placement of the applicator-tissue
interface on the applicator (see FIG. 36). The caregiver is
instructed to scan the RFID tag 158 on the packaging (see FIG. 25).
If the scan confirms that the applicator-tissue interface 16 is
approved for use (see FIG. 37), the caregiver is instructed to
properly place the applicator 14 with the applicator-tissue
interface 16 attached in the facing "in" position on the holster 20
(see FIG. 38) (with the applicator-tissue interface facing the
absorber on the holster 20.
[0206] Regarding RFID communication, the master controller 58
desirably conditions the RFID reader to detect that an appropriate
applicator-tissue interface is being used with the system 10 and to
detect, e.g., reuse, if the applicator-tissue interface 16 is
intended to be a disposable, single use component. The master
controller 58 desirably includes the ability to read secure and
encrypted RFID tags 158 attached to the applicator-tissue interface
packaging (as FIG. 25 shows), which shall include authorization for
a single treatment session (either full treatment or touch-up) and
shall be marked as "used" with the date and time of the start of
the authorized treatment session. The master controller 58 may
retain enough information to restore a guided treatment session to
the last placement not fully completed on interruption of the
treatment session or loss of power, or to restore the exposure
count for a "touch-up" treatment. If it has been longer than, e.g.,
a 4 hour expiration time for the applicator-tissue interface that
is intended to be disposable, resumption of the treatment session
is not allowed until an "un-used" disposable RFID tag is read and
marked as "used". The master controller 58 may include a
"Disposable History" display, listing the date/time a disposable
was marked as "used", for the previous 200 disposables, as a
minimum. If a "used" disposable RFID tag is read, the date and time
the tag was marked as used will be displayed.
[0207] The caregiver is then instructed to choose the mode of
treatment--regular or touch up (see FIG. 39). Caregiver choices are
communicated by touch screen inputs marked by self-apparent,
intuitive icons. If touch up mode is selected before the regular
mode (meaning that there has been no prior treatment applied to the
targeted tissue region), the caregiver is instructed to proceed
with treatment in the touch up mode (see FIG. 58). The touch up
mode in this instance allows the caregiver to directly control the
selection of antennas 24 for treatment.
[0208] If regular mode is selected (see FIG. 29), the caregiver is
guided through a treatment routine. In preparation, the caregiver
is instructed to enter the height and weight of the individual to
be treated (see FIG. 40); to apply the template 176 (the transfer)
(see FIG. 41); to plan on applying anesthesia in a recommended
total amount and in recommended individual aliquots (see FIG. 42);
and to select to treat left armpit first and the right armpit
second, or vice versa (see FIGS. 43 and 44). The caregiver is then
instructed to apply the anesthesia (guided by the template) to the
first side selected (in FIG. 45, it is the right side first), and
then apply anesthesia to the second side selected (in FIG. 46, it
is the left side). The caregiver is then instructed to begin
treatment on the selected right side first (see FIG. 47).
[0209] As FIG. 30 shows, the caregiver is instructed through the
treatment routine, guided by the template (see FIGS. 48, 49, 50,
51, and 52). Guided by the template, the caregiver systematically
proceeds by sections (1 to 12) and by regions (A and B) within each
section to activate the waveguide antenna array 22 under the
control of the master controller 58. The phase drive sequence as
described above is repeated at each region for each section to lay
down a pattern of lesions at each region-section.
[0210] When the treatment routine is completed in one side, the
caregiver is asked whether it wants to proceed to the next side, or
touch up the same side. During touch up, the caregiver can return
to correct lesion formation inconsistencies or gaps. Once touch up
is completed on that side (if selected), the caregiver is prompted
to switch to the next side (see FIG. 53, where the left side is
selected).
[0211] The caregiver is then instructed (see FIG. 53) to choose the
mode of treatment for the second selected side--regular or touch
up, as before described with respect to the first selected side. If
touch up mode is selected before the regular mode (meaning that
there has been no prior treatment applied to the targeted tissue
region on that selected side), the caregiver is instructed to
proceed with treatment in the touch up mode. The touch up mode in
this instance allows the caregiver to directly control the
selection of antennas 24 for treatment on that selected side.
[0212] If regular mode is selected for the second side (as FIG. 53
shows), the caregiver the caregiver is instructed through the
treatment routine, guided by the template (see FIGS. 54 and 55).
Guided by the template, the caregiver systematically proceeds to
treat the second selected side by sections (1 to 12) and by regions
(A and B) within each section to activate the waveguide antenna
array 22 under the control of the master controller 58. The phase
drive sequence as described above is repeated at each region for
each section to lay down a pattern of lesions at each
region-section.
[0213] When the treatment routine is completed in the second side,
the caregiver is asked whether it wants to end the session or touch
up the just completed side (see FIG. 56). During touch up (see FIG.
58), the caregiver can return to correct lesion formation
inconsistencies or gaps. Once touch up is completed on that side
(if selected), or if the caregiver has selected to end the session,
the caregiver is prompted to remove the tissue-applicator interface
from the applicator (see FIG. 57) and clean the applicator for its
subsequent use. switch to the next side (see FIG. 53, where the
left side is selected).
[0214] The graphical user interface 62 may also enable a gear menu
(see FIG. 31). The gear menu (shown in FIG. 59) permits the
caregiver to select operating conditions for the graphical user
interface 62, such as, e.g., prompt volume; screen brightness and
contrast, as well as certain functional operations for the console
and/or applicator, such as coolant purge; power down; cancellation
of a procedure; or a change in power level. The graphical user
interface 62 may also enable the graphical display of error
conditions (see FIG. 31), such as, e.g., equipment failure;
premature termination; or low coolant levels.
[0215] Further details of the form, fit, and function of a
representative graphical user interface 62 are shown in FIGS. 27 to
59.
[0216] According to an embodiment of the invention, a system to
apply energy to a targeted tissue region includes an applicator and
a tissue-applicator interface. The applicator includes an
applicator interior carrying at least one energy emitter. According
to an embodiment of the invention, the tissue-applicator interface
is sized and configured to be attached to the applicator for use in
operative association with the energy emitter and to be detached
from the applicator after use. According to an embodiment of the
invention, the tissue-applicator interface comprises a bio-barrier
system that, when the tissue-applicator interface is attached to
the applicator, isolates the applicator interior from contact with
physiologic liquids in the targeted tissue region. According to an
embodiment of the invention, the bio-barrier system includes a
first bio-barrier component having a prescribed conductivity to
pass energy from the energy emitter to the targeted tissue region
without substantial interference and loss of power.
[0217] According to an embodiment of the invention, the prescribed
conductivity comprises a loss tangent tan .delta. of not greater
than 0.1, where tan .delta.=.sigma./.omega..di-elect cons., where
.sigma. is the conductivity of the first bio-barrier component,
.omega. is the frequency of the energy emitted by the energy
emitter, and .di-elect cons. is the permittivity of the first
bio-barrier component.
[0218] According to an embodiment of the invention, the
tissue-applicator interface includes a tissue acquisition chamber
that acquires tissue in the targeted tissue region for application
of energy in response to negative pressure generated by an external
source and conveyed into the tissue acquisition chamber.
[0219] According to an embodiment of the invention, the bio-barrier
system includes a second bio-barrier component separate from the
first bio-barrier component. According to an embodiment of the
invention, the second bio-barrier is substantially permeable to air
to balance negative pressure between the tissue acquisition chamber
and the applicator interior when the tissue-applicator interface is
attached to the applicator. According to an embodiment of the
invention, the second bio-barrier component is also substantially
impermeable to liquids to isolate the applicator interior from
contact with physiologic liquids in the targeted tissue region
while balancing the negative pressure.
[0220] According to an embodiment of the invention, the first
bio-barrier component is substantially impermeable to air.
[0221] According to an embodiment of the invention, the bio-barrier
system includes a third bio-barrier component separate from the
first and second bio-barrier components. According to an embodiment
of the invention, the third bio-barrier component is substantially
permeable to air to convey negative pressure from the source into
the tissue acquisition chamber. According to an embodiment of the
invention, the third bio-barrier component is also substantially
impermeable to liquids to isolate the source from contact with
physiologic liquids in the targeted tissue region.
[0222] According to an embodiment of the invention, the applicator
includes a cooling plate, that, when the tissue-applicator
interface is attached to the applicator, is sized and configured
for thermal conductive contact with the first bio-barrier
component. According to an embodiment of the invention, the first
bio-barrier component has a prescribed thermal conductivity to
allow thermal conduction to occur between the cooling plate and the
targeted tissue region without substantial interference.
[0223] According to an embodiment of the invention, the prescribed
thermal conductivity of the first bio-barrier component is at least
0.1 watts per meter-Kelvin (0.1 W/mK)
[0224] According to an embodiment of the invention, the applicator
is sized and configured for repeated use, and the applicator is
sized and configured for disposal after a single use.
[0225] According to an embodiment of the invention, the energy
emitter is sized and configured to emit microwave energy.
[0226] According to an embodiment of the invention, instructions
are included for using the system to treat an axilla.
[0227] According to an embodiment of the invention, a system to
apply energy to a targeted tissue region includes an applicator and
a console. According to an embodiment of the invention, the
applicator carries at least one energy emitter and a cooling plate.
The applicator includes an applicator controller communicating with
the energy emitter and a sensor coupled to the cooling plate.
According to an embodiment of the invention, the console includes a
generator to generate a prescribed form of energy, and a cooler to
cool a coolant. According to an embodiment of the invention, the
console includes a master controller including an energy generation
function coupled to the generator to transmit energy to the energy
emitter to form lesions in the targeted tissue region and a lesion
control function coupled to the cooler to circulate coolant to the
coolant plate to control lesion formation. According to an
embodiment of the invention, a special purpose cable system couples
the applicator to the console. According to an embodiment of the
invention, the special purpose cable system includes a cable to
convey energy from the generator to the energy emitter, supply and
return conduits separate from the cable to circulate coolant to the
cooling plate, and communication channels separate from the cable
and supply and return conduits establishing a communication link
between the master controller and the applicator controller.
[0228] According to an embodiment of the invention, the special
purpose cable system includes a far end secured to the applicator
and a near end comprising a connector sized and configured for
releasable connection to a mating special purpose connection site.
According to an embodiment of the invention, the mating special
purpose connection site is on the console.
[0229] According to an embodiment of the invention, the prescribed
form of energy comprises microwave energy.
[0230] According to an embodiment of the invention, the prescribed
form of energy comprises a microwave signal that lays in the ISM
band of 5.775 to 5.825 GHz, with a frequency centered at
approximately 5.8 GHz.
[0231] According to an embodiment of the invention, there are
included instructions for using the system to treat an axilla.
[0232] According to an embodiment of the invention, a method to
apply energy to a targeted tissue region provides a system, which
is operated to form lesions in the targeted tissue region.
[0233] According to an embodiment of the invention, the method
provides instructions for operating the system.
[0234] According to an embodiment of the invention, the lesions are
formed in an axilla.
[0235] According to an embodiment of an invention, the lesions
treat hyperhidrosis.
[0236] Various features of the invention are set forth in the
following claims.
* * * * *